Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
388 participants
INTERVENTIONAL
2010-09-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nasal Steroid
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
Placebo
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo
Intranasal placebo spray
Interventions
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Mometasone Furoate monohydrate
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
Placebo
Intranasal placebo spray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 12% increase in forced expiratory volume at one second (FEV1) after 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 16 mg/ml methacholine); either of these can be available from the last 2 years before enrollment
* Poorly controlled asthma as documented by a score of 19 or less on the Asthma Control Test (ACT) for participants 12 and older, and a Childhood Asthma Control Test (C-ACT) for 6-11 years(both V1 and V2).
* Chronic symptoms of rhinitis and sinusitis as measured by a mean score of 1 on the Sino-nasal questionnaire
* Males and females, age 6 and older
Exclusion Criteria
* Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney or nervous system.
* History of sinus surgery in last 6 months
* Systemic/nasal steroids within last 4 weeks
* Anti-leukotriene medication
* History of upper airway symptoms for less than 8 weeks at the time of enrollment
* Fever \> 38.3 degrees Celsius or patient history of fever in last 10 days
* Greater than 10 pack year smoking history or active smoking within the last 6 months
* FEV1 \< 50% predicted
* Females of childbearing potential that are pregnant or lactating, or unwilling to practice an adequate birth control method
* Allergy or intolerance to nasal mometasone
* Cataracts, history of glaucoma, or other conditions resulting in increased intraocular pressure
* Any investigational drug in the last 6 weeks
* Inability to comply with study procedures, including:
* Inability or unwillingness to provide informed consent (or assent in the case of a minor)
* Inability to take study medication
* Inability to perform baseline measurements
* Completion of less than 10 of the 14 days of screening period diary entry
* Inability to be contacted by phone
* Intention to move out of the area within 6 months
6 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
JHSPH Center for Clinical Trials
OTHER
Responsible Party
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Principal Investigators
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Anne Dixon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of Arizona
Tucson, Arizona, United States
University of California, San Diego
San Diego, California, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Univeristy of Miami School of Medicine
Miami, Florida, United States
University of South Florida College of Medicine
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
North Shore-Long Island Jewish Health System
New Hyde Park, New York, United States
New York University School of Medicine
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Davis Heart and Lung Research Institute
Columbus, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Vermont Lung Center at the University of Vermont
Burlington, Vermont, United States
Univeristy of Virginia
Charlottesville, Virginia, United States
Countries
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Related Links
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ALA-ACRC Webpage
Other Identifiers
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R01 HL089464-01A2
Identifier Type: OTHER
Identifier Source: secondary_id
R01 HL00895101-01A2
Identifier Type: OTHER
Identifier Source: secondary_id
ALAACRC-11
Identifier Type: -
Identifier Source: org_study_id